Venofer

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Venofer

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Serious hypersensitivity reactions, including
anaphylactic-type reactions, some of which have been life-threatening and
fatal, have been reported in patients receiving Venofer. Patients may present
with shock, clinically significant hypotension, loss of consciousness, and/or
collapse. If hypersensitivity reactions or signs of intolerance occur during
administration, stop Venofer immediately. Monitor patients for signs and
symptoms of hypersensitivity during and after Venofer administration for at
least 30 minutes and until clinically stable following completion of the
infusion. Only administer Venofer when personnel and therapies are immediately
available for the treatment of serious hypersensitivity reactions. Most
reactions associated with intravenous iron preparations occur within 30 minutes
of the completion of the infusion [see ADVERSE REACTIONS].

Hypotension

Venofer may cause clinically significant hypotension.
Monitor for signs and symptoms of hypotension following each administration of
Venofer. Hypotension following administration of Venofer may be related to the
rate of administration and/or total dose administered [See DOSAGE AND
ADMINISTRATION and ADVERSE REACTIONS].

Iron Overload

Excessive therapy with parenteral iron can lead to excess
storage of iron with the possibility of iatrogenic hemosiderosis. All adult and
pediatric patients receiving Venofer require periodic monitoring of hematologic
and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin
saturation). Do not administer Venofer to patients with evidence of iron
overload. Transferrin saturation (TSAT) values increase rapidly after
intravenous administration of iron sucrose; do not perform serum iron
measurements for at least 48 hours after intravenous dosing [See DOSAGE AND
ADMINISTRATION and OVERDOSAGE].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with iron
sucrose.

Iron sucrose was not mutagenic in vitro in the bacterial
reverse mutation assay (Ames test) or the mouse lymphoma assay. Iron sucrose
was not clastogenic in the in vitro chromosome aberration assay using human
lymphocytes or in the in vivo mouse micronucleus assay.

Iron sucrose at intravenous doses up to 15 mg/kg/day of
elemental iron (1.2 times the maximum recommended human dose based on body
surface area) had no effect on fertility and reproductive function of male and
female rats.

Use In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies in
pregnant women. In animal reproduction studies, iron sucrose was administered
intravenously to rats and rabbits during the period of organogenesis at doses
up to 13 mg/kg/day of elemental iron (half or equivalent to the maximum
recommended human dose based on body surface area, respectively) and revealed
no evidence of harm to the fetus due to iron sucrose. Because animal
reproductive studies are not always predictive of human response, Venofer
should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether iron sucrose is excreted in human
milk. Iron sucrose is secreted into the milk of lactating rats. Because many
drugs are excreted in human milk, caution should be exercised when Venofer is
administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Venofer for iron replacement
treatment in pediatric patients with dialysis-dependent or
non-dialysis-dependent CKD have not been established.

Safety and effectiveness of Venofer for iron maintenance
treatment in pediatric patients 2 years of age and older with
dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin
therapy were studied. Venofer at doses of 0.5 mg/kg, 1.0 mg/kg, and 2.0 mg/kg
was administered. All three doses maintained hemoglobin between 10.5 g/dL and
14.0 g/dL in about 50% of subjects over the 12week treatment period with stable
EPO dosing. [See Clinical Studies]

Venofer has not been studied in patients younger than 2
years of age.

In a country where Venofer is available for use in children,
at a single site, five premature infants (weight less than 1,250 g) developed
necrotizing enterocolitis and two of the five died during or following a period
when they received Venofer, several other medications and erythropoietin.
Necrotizing enterocolitis may be a complication of prematurity in very low
birth weight infants. No causal relationship to Venofer or any other drugs
could be established.

Geriatric Use

Clinical studies of Venofer did not include sufficient
numbers of subjects aged 65 years and older to determine whether they respond
differently from younger subjects. Of the 1,051 patients in two post-marketing
safety studies of Venofer, 40% were 65 years and older. No overall differences
in safety were observed between these subjects and younger subjects, and other
reported clinical experience has not identified differences in responses
between the elderly and younger patients, but greater sensitivity of some older
individuals cannot be ruled out. In general, dose administration to an elderly
patient should be cautious, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or other drug
therapy.

Last reviewed on RxList: 10/10/2012
This monograph has been modified to include the generic and brand name in many instances.